Equipment Innovations for Pharma Manufacturing

INTERPHEX was back at the Javits Center in NYC in October 2021, and new technologies for facilities and manufacturing were on display, as discussed in the following sections.

Containment

Suppliers of containment systems are seeing increased demand as the use of highly potent ingredients has increased and more companies need to handle materials in higher occupational exposure bands.

Flow Sciences Inc., for example, introduced three new isolators in 2021. The Drysolator is a glovebox designed for powder handling under negative pressure; it protects the operator and controls the relative humidity and oxygen levels to protect substances that are sensitive to moisture and oxygen. The Nitrogenema II glovebox uses a flow of inert gas to nearly eliminate moisture and oxygen, and it can be used for weighing hygroscopic or pyrophoric compounds. The company’s Analytical Process Isolator, designed to protect operators, has an ISO5 interior section with glove ports, as well as a separate open face section that can be used for easier access, such as for cleaning equipment or tools.

ILC Dover displayed its single-use, flexible containment isolators for powder handling. In 2021, the company extended this disposable technology to aseptic isolators with the introduction of the soloPURE flexible aseptic isolator.

Several companies displayed aseptic isolators at INTERPHEX, which will be discussed in an article on PharmTech.com in December. New isolators for cell and gene therapy product manufacturing were featured. One of these, SKAN’s Cellana Series isolator system, was awarded “Best in Show” by the INTERPHEX Exhibitor Awards.

Single-use systems

The demand for both development and commercial manufacturing of biologic drug products is growing, and single-use systems (SUS) that allow a fully disposable flow path have been established as efficient manufacturing equipment components. Multiple companies displayed SUS at INTERPHEX.

Although the supply-chain challenges of 2020 and 2021 caused some components of SUS to be in short supply, SUS manufacturers that are vertically integrated commented that they were able to make their own tubing and bags. The “pinch point” was sourcing the more complex components and the regulatory restrictions that make it more difficult to change components in processes that are already qualified. Standardization vs. customization continues to be debated. Although users like to have custom designs, more standard SUS could help alleviate supply problems. Sterilization capacity was another issue that suppliers are looking to address with the use of alternate sterilization types and materials that can withstand various sterilization forms.

Innovation Stage sessions

Pharmaceutical Technology hosted industry experts remotely on the Innovation Stage on the show floor at INTERPHEX. Check out the videos here:

• Equipment Trends in Advanced Solid-Dosage Drug Manufacturing
• Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies
• Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD
• The Evolution of Aseptic Processing.